22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
22-May-2013 - Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
20-May-2013 - Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
20-May-2013 - Hikma has become the latest injectable manufacturer to take measures to stop its drugs being used in lethal injections.
20-May-2013 - Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.
20-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.
20-May-2013 - EMD Millipore says its new chromatography tech can help manufacturers avoid compromising their processes when switching from multi-use to single use
16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years.
16-May-2013 - Private label gum maker Fertin Pharma has developed an immunity chewing gum that it claims can help guard against the common cold.
16-May-2013 - New UK proposals to label all drugs as “produced as a result of research on animals” have met with muted response from pharmaceutical industry group, the ABPI.
16-May-2013 - The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.
15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
15-May-2013 - Extra filling capacity is to be made available in preparation for West’s Crystal Zenith (CZ) system, though approval and increased sales are still at least 18 months away.
15-May-2013 - Single-use is set to dominate biopharma processing as products become more potent resulting in smaller volumes, according to ATMI.
15-May-2013 - In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500m after pleading guilty to manufacturing and distributing adulterated drugs, according to the US Justice Department settlement agreement.
14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette.